Thursday, 21 October 2010

The ACSM, whose members produce a large proportion of the Specials manufactured in the UK, acknowledges that change is needed within the market and in the last year the ACSM has been consulting with the Department of Health (DH) about a method of controlling the cost of Specials that doesn't compromise the supply to vulnerable patients.

Specials manufacturers in the UK have therefore welcomed the decision (August 19th) by the MHRA to allow manufacturers of unlicensed medicines (specials) to publish price lists. The ACSM, Association of Commercials Specials Manufacturers, believes the move will lead to greater transparency within the sector and help eliminate the practice of excessive price inflation within the distribution chain which has affected the industry‟s reputation in recent months.Specials account for less than 1% of prescriptions, but until now, legislation has prohibited manufacturers from providing any information to healthcare professionals about the unlicensed products they produce unless by specific request from a named healthcare professional. At the same time, the market structure makes it possible to re-sell Specials through a distribution chain over which neither the original manufacturer nor the NHS has control. In this way, the reimbursement price paid is sometimes decided further down the distribution chain and can be significantly different from the original ex-factory prices.

A spokesperson said, “It is a complex area and there are more than 75,000 different Specials formulations. But there is a need for greater transparency and consistency and anyone purchasing a special can now have some benchmark of what the original ex-factory price was and then make a decision about where to purchase.”“The Specials industry has a vital role to play supporting vulnerable patient groups and this is a positive step towards creating greater trust and confidence in our industry.”

About the ACSMThe Specials industry is a highly specialist supplier of pharmaceuticals that are either 'bespoke made to order' or small scale batch manufacture to meet the individual needs of a small section of the patient population whose treatment needs cannot be met with conventional drug formulations. These patients are most often the elderly, the very young and those with complex conditions, such as cancer.

Specials manufacturers are licensed regulated and inspected by the MHRA, must hold a Specials licence and comply with the principles and guidelines of Good Manufacturing Practice (GMP) adopted by the EU Commission to ensure products are consistently produced and controlled to the highest standards to assure the quality for safety, well-being and protection of patients.

ACSM members have invested over £150m in new equipment and product innovation in the last 5 years.